Drug Stability and Chemical Kinetics PDF
Preview Drug Stability and Chemical Kinetics
Muhammad Sajid Hamid Akash Kanwal Rehman Editors Drug Stability and Chemical Kinetics Drug Stability and Chemical Kinetics (cid:129) Muhammad Sajid Hamid Akash Kanwal Rehman Editors Drug Stability and Chemical Kinetics Editors MuhammadSajidHamidAkash KanwalRehman DepartmentofPharmaceuticalChemistry DepartmentofPharmacy GovernmentCollegeUniversity UniversityofAgriculture Faisalabad,Pakistan Faisalabad,Pakistan ISBN978-981-15-6425-3 ISBN978-981-15-6426-0 (eBook) https://doi.org/10.1007/978-981-15-6426-0 #TheEditor(s)(ifapplicable)andTheAuthor(s),underexclusivelicencetoSpringerNatureSingapore PteLtd.2020 Thisworkissubjecttocopyright.AllrightsaresolelyandexclusivelylicensedbythePublisher,whether thewholeorpartofthematerialisconcerned,specificallytherightsoftranslation,reprinting,reuseof illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similarordissimilarmethodologynowknownorhereafterdeveloped. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt fromtherelevantprotectivelawsandregulationsandthereforefreeforgeneraluse. Thepublisher,theauthors,andtheeditorsaresafetoassumethattheadviceandinformationinthisbook arebelievedtobetrueandaccurateatthedateofpublication.Neitherthepublishernortheauthorsorthe editorsgiveawarranty,expressedorimplied,withrespecttothematerialcontainedhereinorforany errorsoromissionsthatmayhavebeenmade.Thepublisherremainsneutralwithregardtojurisdictional claimsinpublishedmapsandinstitutionalaffiliations. ThisSpringerimprintispublishedbytheregisteredcompanySpringerNatureSingaporePteLtd. The registered company address is: 152 Beach Road, #21-01/04 Gateway East, Singapore 189721, Singapore This book is dedicated to Our Beloved and Adorable Little Twinkles Muhammad Aqdas Akash & Zainab Akash Preface Stability studies are essential for certifying safety, efficacy and quality of drug productstoassesstheirshelflife.Thesestudiesassurethatpharmaceuticalproducts will exhibit constant efficacy under specified storage conditions. Developments in pharmaceuticalindustryshownovelwaysforpreservingthequalityofpharmaceu- tical preparations. Stability is vital for protection, value and quality of a drug. The investigation of drug stability is essential to improve quality, safety and efficacy. Drug toxicity and its adverse effects can be prevented by evaluating parameters relatedtostability.Uponstorage,pharmaceuticalproductsarevulnerabletochemi- calandphysicaldegradation.Thesedegradationsalterpharmacologicalpropertiesof a drug resulting in reduced benefits and increased toxicity. Physical factors that influencethestabilityofpharmaceuticalsareheat,ionicstrength,acid-basecatalysis, solvent,lightandradiations,oxygen,particlesizedistributionandmoisture. Advancedkineticmodelsareusedtocalculatethedegradationrateofbiological products, such as protein and virus-based vaccines and emulsion-based adjuvant vaccines. Statistical tools are used to select an optimal number based on variable parameters and analyse experimental data obtained from various steps of kinetic models. Thisbook“DrugStabilityandChemicalKinetics”providesanintroductiontothe principles of pharmaceutical analysis in drug stability and chemical kinetics, proposes guidelines for drug stability and stability testing, and mentions methods and protocols for drug stability studies and degradation factors of pharmaceutical products,includingphysical,chemicalandmicrobialdegradationaswellasroleof decomposition, catalysis and catalytic agents. Finally, it explains various kinetic modelsindrugstabilitypreventionandtherapeuticintervention. This book provides comprehensive and up-to-date information regarding the principlesofpharmaceuticalanalysisindrugstabilityandchemicalkinetics. There exists an enormous gap in knowledge between the fundamentals of drug stability and the role of chemical kinetics. This book aims to link the gap existing between drug stability as well as its factors and chemical kinetics as well as its factors.Therefore,thisbookprovidesbetterunderstandingabouteachvitalcompo- nentofdrugstabilityandchemicalkinetics. Byimplication,chaptersofthisbookmentiontheemergingareasofresearchin this field and various environmental factors that affect drug quality by physical or vii viii Preface chemical degradation.The book alsodiscusses types andmethodsofstabilitytests andstorageconditionsaswellasICHandWHOguidelines. This book includes in-depth assessments about various analytical methods and protocols for drug stability studies and factors involved in drug degradation by influencingitskineticprofile.Weassurethisbookwillinspireandshowinnovative pathsofresearchtoincrease knowledge,awarenessandresponsivenessaboutdrug stabilitystudies. Faisalabad,Pakistan MuhammadSajidHamidAkash Faisalabad,Pakistan KanwalRehman Acknowledgements We express our sincere thanks to chapter authors who supported and cooperated a lot.Thisbookisnotpossiblewithoutalltheirefforts.Wewholeheartedlyacknowl- edgethecontributionofeachauthorthatwasessentialforthisaccomplishment. ThesupportandtechnicalcontributionofHigherEducationCommission(HEC) of Pakistan is highly significant. Without its provision and funding, it would have beenimpossibletocompletethisresearch.Thecreditfortheaccomplishmentofthis work goes to the research grants (21-667/SRGP/R&D/HEC/2016, 21-1061/SRGP/ R&D/HEC/2016, 5661/Punjab/RPU/R&D/HEC/2016, 6429/Punjab/NRPU/R&D/ HEC/2016 and 8365/Punjab/RPU/R&D/HEC/2017) sanctioned by HEC. We are highlyindebtedtoHECasthisfundingwasthekeyforthesuccessofthisproject. Lastbutnotleast,wethankSpringerPublishersforprovidingustheplatformto publishthisbookandcontributeessentialinformationinthisfield. ix Contents 1 PrinciplesofPharmaceuticalAnalysisinDrugStability andChemicalKinetics. . . . . . . .. . . . . . . .. . . . . . . . .. . . . . . . . .. 1 KanwalIrshad,MuhammadSajidHamidAkash,KanwalRehman, andImranImran 2 GuidelinesforDrugStabilityandStabilityTesting. . . . . . . . . . . . . 19 KamranHaider,MuhammadSajidHamidAkash,AmnaFaheem, andKanwalRehman 3 ChemicalKineticsandItsApplicationsinDrugStability. . . . . . . . 31 MutayybaFatima,MuhammadSajidHamidAkash, MuhammadFawadRasool,andKanwalRehman 4 MethodsandProtocolsforDrugStabilityStudies. . . . . . . . . . . . . . 43 HammadAhmed,WaseemHassan,GhulamMurtaza,SaharBakht, andFurqanMuhammadIqbal 5 PhysicalBasisofDegradationofPharmaceuticalProducts. . . . . . . 57 TauqeerHussainMallhi,RabiaKhokhar,AishaKhokhar, SyedNasirAbbasBukhari,andYusraHabibKhan 6 RoleofMicrobialDegradationonDrugStability. . . . . . . . . . . . . . 71 YusraHabibKhan,MariaRasheed,NasserHadalAlotaibi, SyedNasirAbbasBukhari,andTauqeerHussainMallhi 7 RoleofDecompositiononDrugStability. . . . . . . . . . . . . . . . . . . . . 83 YusraHabibKhan,AbrarAhmad,MuhammadHammadButt, ShahzadiMisbah,MuhammadShahidIqbal, andTauqeerHussainMallhi 8 RoleofCatalysisandCatalyticAgentsinDrugStability. . . . . . . . . 95 SanaGhayas,KiranQadeer,andZubairAnwar 9 AnalyticalTechniquesfortheAssessmentofDrugStability. . . . . . 121 AnamAhsan,Qurat-ul-ainAslam,AjabKhan, MirzaMuhammadFaranAshrafBaig,MuhammadAsimFarooq, QuratUlAin,DicksonPiusWande,andWen-xiaTian xxii xii Contents 10 StabilityofPharmaceuticalProducts. . . . . . . . . . . . . . . . .. . . . . . . 147 QudsiaRehman,MuhammadSajidHamidAkash,ImranImran, andKanwalRehman 11 RoleofKineticModelsinDrugStability. . . . . . . . . . . . . . . . . . . . . 155 QudsiaRehman,MuhammadSajidHamidAkash, MuhammadFawadRasool,andKanwalRehman 12 StabilityStudiesofVaccines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167 AjabKhan,AnamAhsan,MuhammadAsimFarooq, MirzaMuhammadFaranAshrafBaig,andQurat-ul-ainAslam 13 StabilityStudiesofProteinousCompounds. . . . . . . . . . . . . . . . . . . 187 SaimaMuzammil,RahatAndleeb,MariaRasool,FarkhandaAsad, andAsmaAshraf 14 StabilityStudiesofExtemporaneousPharmaceuticalProducts. . . . 237 TauqeerHussainMallhi,RabiaKhokhar,AishaKhokhar, NasserHadalAlotaibi,andYusraHabibKhan 15 StabilityStudiesofParenteralProducts. . . . . . . . . . . . . . . . . . . . . 247 QuratUlAin,MuhammadAsimFarooq,BilgenCaliskan, AnamAhsan,MdAquib,ZahidHussain,andBoWang 16 StabilityStudiesofSolidDosageForms. . . . . . . . . . . . . . . . . . . . . 265 GhulamMurtaza,MunazzaIjaz,HafsaAnam,andSabaShamim
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